Senior Manager, Analytical Development

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 140,000 - 180,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Verona, WI is seeking a Senior Manager to lead a team of CMC analytical scientists in method development, validation, and characterization for drug substance and drug product candidates.

You will mentor staff, set goals, and ensure GMP-compliant deliverables for regulatory dossiers. The role reports to the Director of Analytical Development and is a full-time onsite position involving collaboration with Process Development, QA/QC, and Regulatory teams to meet

Qualifications

• B.S, M.S or PhD in Chemistry (or related area of study)
• PhD. with 5+ years of relevant experience / M.S. with 7+ years of relevant experience / B.S. with 10+ years of relevant experience.
• Demonstrated expertise with analytical instrumentation theory and practice.
• Demonstrated experience with pharmaceutical drug substance development and processes.

Responsibilities

• Leads a team of CMC analytical scientists including managerial duties like goal setting, performance feedback and talent development.
• Provides leadership and mentoring to AD scientists; works with team to set and track annual goals and HR documentation.
• SME in analytical techniques and GMP activities for method development/validation, characterization, sample analyses, and documentation for drug substance and drug product development.

Skills

Team leadership

SME

Analytical techniques

GMP

Regulatory knowledge

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

HPLC/LC-MS

Analytical instrumentation

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Senior Manager will lead a team of CMC analytical scientists (AAS, AS/BS, MS, PhD) in the development and validation of new analytical test methods, as well as performing thorough characterization for Arrowhead’s new drug substance and drug product candidates. They will be accountable for the team’s testing required for drug substance and drug product process development, characterization of impurities, and other activities associated with GLP Toxicology and cGMP Clinical Trial materials. They will provide career and technical mentoring for the team’s individuals. This position reports to the Director of Analytical Development.

This role is full-time onsite, 5 days a week in Verona, WI.

Responsibilities

• Ensures the security of proprietary and company information while performing duties and tasks
• Works independently and/or as part of a team to meet project timelines and deliverables
• Maintains an orderly and safe working environment
• Leads a team of CMC analytical scientists including managerial duties like goal setting, performance feedback and talent development. Provides leadership and mentoring (technical and career development guidance) to AD scientists; works collaboratively with team members to construct and track personal annual goals and completes HR requisite documentation and reviews.
• Is a Subject Matter Expert (SME) in various analytical techniques and GMP activities required for method development/validation, characterization, sample analyses, and documentation in support of drug substance and drug product development
• Builds team proficiency in the practice of method development, validation, and characterization studies as well as GMP requirements in support of drug substance and drug product projects in development and manufacturing
• Proactively problem solves and provides clear direction for team members
• Prioritizes the team’s workload consistent with individual’s training and expertise, as well as, aligned with departmental priorities
• Leads the development and validation of test methods, product and process characterization, Certificate of Analysis, Summaries of Results, Departmental Memo of Results, etc. for raw materials, in-process and isolated intermediates, final drug substances and drug products
• Makes sound scientific decisions and serves as back-up to upper management
• Stays current with new and emerging analytical techniques related to Arrowhead’s products
• Represents the AD function on project teams and collaborates with cross-functional partners to ensure project deliverables and timeline expectations are met.
• Works collaboratively with cross-functional teams (Process Development, PM, QA, QC, Regulatory and others as needed) to develop and meet project goals, deliverables, and timelines
• Leads the preparation of technical reports, presentations, SOPs, WI, policies, and procedures
• Authors regulatory dossier sections pertaining to CMC Analytical Chemistry
• Performs peer review of notebooks, protocols, and validation documentation
• Ensures work is compliant with cGMP and relevant regulatory requirements
• Works with third party vendors and CDMOs to assure Arrowhead’s quality standards and project deliverables are maintained
• Performs other duties as assigned

Requirements

• B.S, M.S or PhD in Chemistry (or related area of study)
• PhD. with 5+ years of relevant experience / M.S. with 7+ years of relevant experience / B.S. with 10+ years of relevant experience.
• Demonstrated expertise with analytical instrumentation theory and practice.
• Demonstrated experience with pharmaceutical drug substance development and processes.

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.